MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD ULTRA COREGA CREAM WITHOUT FLAVOUR; DENTURE ADHESIVE

Lot Number 8H4V

Device Problem Product Quality Problem (1506)

Patient Problem Pain (1994)

Event Date 03/22/2022

Event Type  Injury  

Event Description

I almost died choked [choking].It hurt my mouth [oral pain].It cut all the roof of my mouth [cuts in mouth].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a female patient who received double salt dental adhesive cream (ultra corega cream without flavour) cream (batch number 8h4v, expiry date 30th january 2024) for denture wearer.This case was associated with a product complaint.On an unknown date, the patient started ultra corega cream without flavour.On (b)(6) 2022, an unknown time after starting ultra corega cream without flavour, the patient experienced choking (serious criteria gsk medically significant), oral pain and cuts in mouth.On an unknown date, the patient experienced product complaint.The action taken with ultra corega cream without flavour was unknown.On an unknown date, the outcome of the choking, oral pain and cuts in mouth were recovering/resolving and the outcome of the product complaint was unknown.It was unknown if the reporter considered the choking to be related to ultra corega cream without flavour.The reporter considered the oral pain and cuts in mouth to be related to ultra corega cream without flavour.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received via call center representative (phone) on 23mar2022.Consumer reported that," i bought corega, i almost swallowed my protest, it did not fix it, i almost died choked, when i ate it came loose, where you already saw this, i want my money back, they told me saying it was good, it hurt my mouth, it cut all the roof of my mouth.".

Manufacturer Narrative

Argus case id: (b)(4).

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a female patient who received double salt dental adhesive cream (ultra corega cream without flavour) cream (batch number 8h4v, expiry date 30th january 2024) for denture wearer.This case was associated with a product complaint.On an unknown date, the patient started ultra corega cream without flavour.On (b)(6) 2022, an unknown time after starting ultra corega cream without flavour, the patient experienced choking (serious criteria gsk medically significant), oral pain and cuts in mouth.On an unknown date, the patient experienced product complaint.The action taken with ultra corega cream without flavour was unknown.On an unknown date, the outcome of the choking, oral pain and cuts in mouth were recovering/resolving and the outcome of the product complaint was unknown.It was unknown if the reporter considered the choking to be related to ultra corega cream without flavour.The reporter considered the oral pain and cuts in mouth to be related to ultra corega cream without flavour.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received via call center representative (phone) on 23mar2022.Consumer reported that," i bought corega, i almost swallowed my protest, it did not fix it, i almost died choked, when i ate it came loose, where you already saw this, i want my money back, they told me saying it was good, it hurt my mouth, it cut all the roof of my mouth." follow up information was received on 05may2022 from quality assurance (qa) department regarding (b)(4) (issue number) for 8h4v lot number and expiry date 30jan2024.Investigation evaluation: this is the eleventh complaint of this nature for this batch.No complaint sample was received to site.The retain sample was recalled to site and sent to the lab for testing.The testing of the complaint sample has met the required quality standards.The investigation reports concluded that complaint stands unsubstantiated.Pqc number was reported as (b)(4).

• Brand Name: ULTRA COREGA CREAM WITHOUT FLAVOUR
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 14024138
• MDR Text Key: 288691622
• Report Number: 3003721894-2022-00040
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2024
• Device Lot Number: 8H4V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 05/05/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1) NO THERAPY (NO THERAPY).
• Patient Outcome(s): Other
• Patient Sex: Female